The Acumed Tension Band Pin is a fixation pin which is — Class II medical device recall Z-1516-2014
Terminated recall by Acumed LLC, reported 2014-05-07, distributed nationwide. Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured w
| Recall number | Z-1516-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acumed LLC, Hillsboro, OR, United States |
| Recall initiated | 2014-03-26 |
| Classified | 2014-04-25 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, ES, FR, GB, IT, JP, KR, SE, ZA |
| Lot numbers | 210290, 211349, 214574, 215053, 215405, 216769, 217002, 217004, 217005, 217941, 218273, 218600, 218700, 219145, 219230, 219402, 220978, 221465, 221503, 222731, 222732, 223007, 223008, 223009, 223477, 223756, 224066, 224312, 225554, 225555, 227193, 228951, 229394, 229889, 230287, 230952, 231573, 231971, 232575, 233742 and 37 more |
| Model numbers | 30-0097, 30-0098, 30-0099, 50.0, 70.0, 90.0, TB-1550K-S, TB-1570K-S, TB-1590K-S |
Product
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
Reason for recall
Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1516-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.